LEVORPHANOL TARTRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

levorphanol tartrate (UNII: 04WQU6T9QI) (levorphanol - UNII:27618J1N2X)

Available from:

Sentynl Therapeutics, Inc.

INN (International Name):

levorphanol tartrate

Composition:

levorphanol tartrate 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levorphanol Tartrate Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve Levorphanol Tartrate Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia Levorphanol Tartrate Tablets are contraindicated in patients with: - Significant respiratory depression [see WARNINGS ] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] - Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] - Hypersensitivity to levorphanol or any of the formulation excipients (e.g., anaphylaxis) [see WA

Product summary:

Levorphanol Tartrate Tablets USP Bottles of 100 tablets. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in an amber airtight container as defined in the USP. Store Levorphanol Tartrate Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients/Caregivers ]. Manufactured for: Sentynl Therapeutics, Inc. Solana Beach, CA 92075

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Sentynl Therapeutics, Inc.
----------
Medication Guide
Levorphanol Tartrate (lee vor' fa nol tar' trate) Tablets, CII
Levorphanol Tartrate Tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain,
severe enough to require an opioid pain medicine when other pain
treatments such as non-opioid pain
medicines do not treat your pain well enough or you cannot tolerate
them.
•
An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your dose
correctly as prescribed you are at risk for opioid addiction, abuse,
and misuse that can lead to death.
Important information about Levorphanol Tartrate Tablets:
•
Get emergency help or call 911 right away if you take too much
Levorphanol Tartrate Tablets
(overdose). When you first start taking Levorphanol Tartrate Tablets,
when your dose is changed, or
if you take too much (overdose), serious or life-threatening breathing
problems that can lead to death
may occur. Talk to your healthcare provider about naloxone, a medicine
for the emergency treatment
of an opioid overdose.
•
Taking Levorphanol Tartrate Tablets with other opioid medicines,
benzodiazepines, alcohol, or other
central nervous system depressants (including street drugs) can cause
severe drowsiness, decreased
awareness, breathing problems, coma and death.
•
Never give anyone else your Levorphanol Tartrate Tablets. They could
die from taking it. Selling or
giving away Levorphanol Tartrate Tablets is against the law.
•
Store Levorphanol Tartrate Tablets securely, out of sight and reach of
children, and in a location not
accessible by others, including visitors to the home.
Do not take Levorphanol Tartrate Tablets if you have:
•
severe asthma trouble breathing, or other lung problems
•
a bowel blockage or have narrowing of the stomach or intestines.
•
previously had an allergic reaction to levorphanol
Before taking Levorphanol Tartrate Tablets, tell your healthcare
provider if you have a history of:
•
head injury,

Summary of Product characteristics

LEVORPHANOL TARTRATE- LEVORPHANOL TARTRATE TABLET
SENTYNL THERAPEUTICS, INC.
----------
LEVORPHANOL TARTRATE TABLETS USP, CII
Revised: January 2021
RX ONLY
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND
MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY
DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL
SYNDROME; AND RISKS FROM CONCOMITANT USE WITH
BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
ADDICTION, ABUSE, AND MISUSE
LEVORPHANOL TARTRATE TABLETS EXPOSES PATIENTS AND OTHER USERS TO THE
RISKS OF OPIOID ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO
OVERDOSE
AND DEATH. ASSESS EACH PATIENT'S RISK PRIOR TO PRESCRIBING LEVORPHANOL
TARTRATE TABLETS, AND MONITOR ALL PATIENTS REGULARLY FOR THE
DEVELOPMENT
OF THESE BEHAVIORS AND CONDITIONS [SEE WARNINGS].
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS):
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION, ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA)
HAS REQUIRED A REMS FOR THESE PRODUCTS [SEE WARNINGS]. UNDER THE
REQUIREMENTS OF THE REMS, DRUG COMPANIES WITH APPROVED OPIOID
ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS
AVAILABLE TO HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY
ENCOURAGED TO
COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM,
COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON
SAFE USE, SERIOUS RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS,
EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING
THE MEDICATION GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST,
AND
CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY
SAFETY.
LIFE-THREATENING RESPIRATORY DEPRESSION
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR
WITH
USE OF LEVORPHANOL TARTRATE TABLETS. MONITOR FOR RESPIRATORY
DEPRESSION,
ESPECIALLY DURING INITIATION OF LEVORPHANOL TARTRATE TABLETS OR
FOLLOWING A
DOSE INCREASE [SEE WARNINGS].
ACCIDENTAL INGESTION
ACCIDENTAL INGESTION OF LEVORPHANOL TARTRATE TABLETS, ESPECIALLY BY
CHILDRE